NCT05069428

Delirium Reduction With Ramelteon

• Status: Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 506 (estimated)
• Sponsor: Centennial Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The overall purpose of this study is to identify a medication that might treat and/or prevent delirium in intensive care unit (ICU). Currently, there is no proven medical therapy for prevention or treatment of delirium. Ramelteon is a medication approved for insomnia. We hypothesize that ramelteon may help regulate the day/night cycle and decrease ICU delirium.

Detailed description

Melatonin is an endogenous hormone that regulates the sleep-wake cycle along with several other physiological functions. It is reported that melatonin secretion may be impaired in ICU patients, and there is some question whether this may be a contributing factor to delirium occurrence. Ramelteon is a melatonin agonist with three to six times increased affinity for MT1 and MT2 receptors versus melatonin. It is FDA approved for the treatment of insomnia, and some studies suggested some benefit with ramelteon for delirium prevention. There is limited prospective research data assessing the efficacy of ramelteon for delirium treatment. The goal of this study therefore is to assess the efficacy of ramelteon versus placebo on the prevention and treatment of delirium in ICU patients.

Conditions

• Delirium

Interventions

Type	Name	Description
DRUG	Ramelteon 8mg	administered crushed, orally at 20:30

Timeline

• Start date: 2023-03-26
• Primary completion: 2025-03-01
• Completion: 2025-12-01
• First posted: 2021-10-06
• Last updated: 2024-08-22

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study